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Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group
Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M.. The Journal of clinical psychiatry, 1999-02-01
Topic: Risk, prevention and care in population studies
Background We report the findings from the first large, double-blind, placebo-controlled study conducted to evaluate the efficacy and safety of risperidone in the treatment of psychotic and behavioral symptoms in institutionalized elderly patients with dementia. Method 625 patients (67.8% women; mean age = 82.7 years) with DSM-IV diagnoses of Alzheimer's disease (73%), vascular dementia (15%), or mixed dementia (12%) and significant psychotic and behavioral symptoms were included. Each patient was randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day, or 2 mg/day of risperidone for 12 weeks. The primary outcome measure was the Behavioral Pathology in Alzheimer's Disease rating scale (BEHAVE-AD). Results The study was completed by 70% of the patients. Baseline Functional Assessment Staging scores were 6 or 7 in more than 95% of the patients, indicating severe dementia. At endpoint, significantly greater reductions in BEHAVE-AD total scores and psychosis and aggressiveness subscale scores were seen in patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p Conclusion Risperidone significantly improved symptoms of psychosis and aggressive behavior in patients with severe dementia. Results show that 1 mg/day of risperidone is an appropriate dose for most elderly patients with dementia.
Key findings
- Method 625 patients (67.8% women; mean age = 82.7 years) with DSM-IV diagnoses of Alzheimer's disease (73%), vascular dementia (15%), or mixed dementia (12%) and significant psychotic and behavioral symptoms were included.
- Results The study was completed by 70% of the patients.
- At endpoint, significantly greater reductions in BEHAVE-AD total scores and psychosis and aggressiveness subscale scores were seen in patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p < .001, respectively).
- Results show that 1 mg/day of risperidone is an appropriate dose for most elderly patients with dementia.
Why it matters
In this 12-week trial of 625 patients with severe dementia, risperidone at 1 and 2 mg/day reduced psychosis and aggression scores more than placebo. It treats behavioral symptoms only and does not affect the underlying disease or its progression.
Study details
- Participants625
- Effect size67.8%; or 0.5
- Evidence strengthLow
How this study scored 68/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. We have no data on senior author's track record, so that was left out: it earned 65 of the 96 points we could judge it on, which is 68 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The Journal of clinical psychiatry) |
| Journal's citation record | 2 / 4 | The Journal of Clinical Psychiatry: journal h-index 248 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 1999 — older than 20 years, still counted |
| Sample size | 2 / 4 | 625 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 748 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 25.8 citations a year over 29 year(s) since 1999 |
| Impact for its field and year | 6 / 6 | Cited 43.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 19 other studies in this library |
| Still being cited | 1 / 4 | Cited 13 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 2 / 3 | University of Pennsylvania: institution h-index 1,859 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 10084637) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 65 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 65 of the 96 points we could judge it on is 68 out of 100. |
| Total | 68 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Katz, I. R., Jeste, D. V., Mintzer, J. E., Clyde, C., Napolitano, J., & Brecher, M. (1999). Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. The Journal of clinical psychiatry. https://doi.org/10.4088/jcp.v60n0207
Vancouver
Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. The Journal of clinical psychiatry. 1999. doi:10.4088/jcp.v60n0207. PMID: 10084637.
BibTeX
@article{katz1999-10084637,
author = {Katz, I. R. and Jeste, D. V. and Mintzer, J. E. and Clyde, C. and Napolitano, J. and Brecher, M.},
title = {{Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group}},
journal = {The Journal of clinical psychiatry},
year = {1999},
doi = {10.4088/jcp.v60n0207},
pmid = {10084637},
url = {https://doi.org/10.4088/jcp.v60n0207}
}
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